Citric acid
As of the edition of 20 October 2026, Citric acid is a small molecule: marketed, first approved in 1970 (ES); no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Small molecule
- Brand name
- Irrigating Solution G In Plastic Container
- First approved
- 1 December 1970 (ES)
- Approvals on record
- 14 in 6 regions
- Holder of the most recent approval
- Neothetics; 9 holders in all
- Registered trials
- 27, 4 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Injuries; Bones, joints and muscles; Cancer; Infections
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Neothetics holds a later exclusivity on its own new formulation or combination product, ending 2033; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 4 | 1 | 0 |
| Phase 1 | 3 | 0 | 2 | 1 |
| Phase 2 | 4 | 0 | 1 | 2 |
| Phase 3 | 6 | 4 | 0 | 1 |
| Phase 4 | 6 | 4 | 0 | 0 |
| All trials | 27 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| B. Braun Medical | Applicant | 1993 to now |
| Ferring Pharmaceuticals | Later holder and Lead sponsor of trials | 2004 to now |